Abdominal Midline Wound Closure: Small Tissue Bites Versus Large Tissue Bites
The goal of this clinical trial is to learn whether a small stitch technique works better than a large bite technique for closing midline abdominal surgery wounds in adults having midline laparotomy surgery.
The main questions it aims to answer are:
Does the small stitch technique lower the risk of surgical site infection? Does the small stitch technique lower the risk of wound dehiscence (reopening of the wound)? Researchers will compare the small stitch technique with the large bite technique to see if the small stitch technique leads to fewer wound complications after surgery.
Participants will:
Have their abdominal wound closed using either the small stitch or large bite technique during surgery Attend follow-up visits at 2 weeks and 1 month after surgery Be checked for wound complications, including infection and wound reopening In the small stitch technique, stitches are placed 5 millimeters from the wound edge and 5 millimeters apart. In the large bite technique, stitches are placed 10 millimeters apart.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This clinical trial is designed to evaluate two different methods of closing abdominal wounds after midline laparotomy surgery in adults. A midline laparotomy is a common surgical procedure in which an incision is made along the middle of the abdomen to allow surgeons access to internal organs. Proper closure of this incision is important because complications such as infection or reopening of the wound can lead to pain, delayed recovery, longer hospital stays, and additional treatment.
The study focuses on comparing a "small stitch" technique with the more traditional "large bite" technique used to close the abdominal wall at the end of surgery. Researchers want to determine whether the small stitch method can improve healing and reduce complications after surgery.
In the small stitch technique, sutures are placed approximately 5 millimeters from the edge of the wound and spaced 5 millimeters apart. This approach is designed to distribute tension more evenly across the wound and may help preserve blood supply to the tissues, potentially improving healing. In the large bite technique, stitches are placed farther from the wound edge and farther apart, which is the conventional method commonly used in many surgical settings.
The main goals of the study are to determine:
Whether the small stitch technique reduces the risk of surgical site infections Whether the small stitch technique lowers the chance of wound dehiscence, a serious complication in which the surgical wound partially or completely reopens after surgery Adults undergoing midline laparotomy surgery may be eligible to participate. During the procedure, participants will have their abdominal incision closed using either the small stitch or the large bite technique. The method used will be assigned according to the study protocol so that researchers can fairly compare outcomes between the two groups.
After surgery, participants will continue with routine postoperative care and attend follow-up visits approximately 2 weeks and 1 month after their operation. At these visits, the surgical wound will be examined for signs of infection, delayed healing, wound reopening, pain, or other complications. Researchers will collect and compare the results from both groups to determine which closure method provides better outcomes.
The information gained from this study may help surgeons identify the safest and most effective way to close abdominal incisions, potentially improving recovery and reducing postoperative complications for future patients undergoing abdominal surgery.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Karachi, Paquistão, 75510
- Indus Hospital and Health Network
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
. Age 18-80 years, either sex
- Midline laparotomy (elective or emergency)
- ASA class I-IV
Exclusion Criteria:
- Previous incisional hernia or midline incision
- Contaminated surgery
- ASA V-VI
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Small Stitch Closure Technique
Participants in this arm will undergo abdominal wall closure using the small stitch technique following midline laparotomy surgery.
|
In this technique, sutures are placed approximately 5 millimeters apart using a continuous suturing method.
Outros nomes:
|
|
Comparador Ativo: Large Stitch Closure Technique
Participants in this arm will undergo abdominal wall closure using the large stitch technique following midline laparotomy surgery
|
In this technique, sutures are placed approximately 10 millimeters apart using a continuous suturing method.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Sheath Dehiscence
Prazo: 30 days
|
Abdominal fascial (sheath) dehiscence, defined as partial or complete separation of the abdominal fascial closure with or without evisceration, assessed by clinical examination of the surgical wound by the treating surgical team.
The outcome will be reported as the number of participants who develop fascial dehiscence during the follow-up period.
|
30 days
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Skin dehiscence
Prazo: 30 days
|
Postoperative skin wound dehiscence, defined as partial or complete separation of the skin edges of the surgical incision, assessed by standardized clinical wound examination performed during postoperative follow-up.
The outcome will be reported as the number of participants who develop skin wound dehiscence.
|
30 days
|
|
Southampton wound grading
Prazo: 30 days
|
normal healing, erythema, discharge, purulence
|
30 days
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Nazia Lodhi, MBBS, FCPS, Indus Hospital and Health Network
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- IHHN_IRB_2024_03_014
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .